Evaluation of a Novel Nasal Conformer in Pediatric Patients
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ease of use
研究概览
简要总结
This study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. This will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. This study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's undergoing primary cleft lip repair or release of nasal scarring
排除标准
- •patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate
研究组 & 干预措施
Standard first, anatomic second
Patients are started with the standard nasal conformer for the first 3 months and then switched to the anatomic conformer for the second 3 months
干预措施: use of an anatomically designed nasal conformer (Device)
Anatomic first, standard second
Patients are started with the anatomic nasal conformer for the first 3 months and then switched to the standard conformer for the second 3 months
干预措施: use of an anatomically designed nasal conformer (Device)
结局指标
主要结局
Ease of use
时间窗: 6 months
The patients or (parents for younger patients) will complete a questionnaire at the end of 3 months and 6 months after using each of the various types of conformer. These questionnaires will consist of a grading scale evaluating each of the conformer is a based on the ease of cleaning, inserting, and keeping the stent in place is evaluated
safety of the conformer
时间窗: 6 months
The patients or (parents of younger patients) will complete a questionnaire at the end of 3 months and 6 months after using each of the various types of conformer. The these will give them the opportunity to report the occurrence of adverse events such as skin rashes, skin irritation, skin breakdown, or stent breakage.
次要结局
未报告次要终点
研究者
Justin Daggett
Principal Investigator
East Tennessee Children's Hospital